Webinar On International product registrations – Lessons Learned?

Description :

The focus of this session is international product registration for IVDs & Medical Devices. Product registrations requirements have changed with new regulations across the globe. Requirements have been clarified and in some cases the registration timeframe has been reduced.

Industry Executives and investors are complaining these days that their competitive edge is being jeopardized by the heightened regulatory scrutiny. For device companies based in the US, there is a growing trend in commercializing their products outside the country. In particular, many US-based companies are targeting new markets in the EU, China and, increasingly, India.

The process for approval or clearance of devices varies from regulatory body to regulatory body. In some cases, products achieve regulatory approval in an efficient and timely manner. In others, including the US FDA, companies may face a protracted and delayed approval process. Recent scrutiny by US regulators and legal authorities is making it more uncertain for companies attempting to gain market access in foreign countries.

In an economy where getting the jump on your competitors is so important, this training will provide a guide to ease international registrations and reduce time to market. Learning the relevant regulatory requirements and the appropriate document legalization path will speed up the pathway.

Areas Covered in the Session :

International regulation- Overview of country by country differences

Role and responsibilities of US manufacturers & in-country distributors

Identifying the key players

Working with in-country distributors

Sales forecasting – Who needs to know?

Types of documents need

Medical Device & IVDs

Best practices for document legalizations

Apostille vs. Authentications

How to get documents embassy legalized

Pitfalls – What to look out for.

Who Will Benefit:

Regulatory Affairs Specialists

Regulatory Affairs Managers

Product Managers

Marketing Professionals

Administrative Professionals

Teams involved in new product registration